Recall Z-1667-2025 · MEA Pump, Infusion, Pca
Smiths Medical ASD, Inc.
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR FUKUOKA 21-2111-0300-09_FUK CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR
| Date | May 7, 2025 (initiated Apr 10, 2025) |
| Status | Open, Classified |
| Reason | Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death. |
| Root cause | Labeling design |
| Action | On April 10, 2025, the firm notified affected consignees via letters titled "Urgent Medical Device Correction." Customers were informed of conditions under which the false Upstream Occlusion Alarm may occur. The USO alarm can be cleared during these conditions by removing the administration from the pump, re-attaching the administration set, and restarting delivery. Customers should verify there is no upstream occlusion present. The firm will be making an update to the Infusion Pump Operator's Manual to include these conditions. |
| Quantity | 185,975 US; 127,701 OUS Total |
| Distribution | Worldwide - US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072144 | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR Smiths Medical MD, Inc., Mar 7, 2008 |
| K130394 | CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 Smiths Medical Asd, Inc., Dec 9, 2013 |
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Ad Smiths Medical Ads, Inc., Aug 24, 2017 |